Pharma chromatography and CIP system

Brinox LEP 11

Year of construction: 2020, condition: new, functionality: fully functional, Equipment: documentation/manual, BRINOX LEP 11 – Chromatography Panel / CIP Skid – Module PP6713 – NEW Manufacturer: BRINOX Process Systems Model / Type: LEP 11 – Chromatography Panel / CIP Skid Year of Manufacture: 2020 Condition: New – original packaging – unused Location: Germany Brief Description: Original packaged, as-new chromatography and CIP skid unit BRINOX LEP 11 (Module PP6713) in a pharmaceutical-grade design. This unit was project-built, left unused, and is fully documented and traceable by materials. The module is suitable for hygienic process media, ideally for integration in pharmaceutical chromatography, cleaning, and material circuits. Technical Data: Product type: Chromatography Panel / CIP Skid Manufacturer: BRINOX Process Systems Module designation: PP6713 Year: 2020 Condition: New – original packaging Product-contact materials: Stainless steel 1.4435 / 1.4404 / 1.4301 Piping system: Classic hygienic stainless steel piping Connections: Clamp DIN 32676 or equivalent Valve technology: Pneumatically actuated process valves + manual ball valves Insulation: Partial Armaflex or similar insulation Instrumentation: Pressure and temperature measurement points, digital displays Electrics: Integrated junction box Installation: Skid / frame-mounted Features: Hygienic stainless steel piping installation Integrated measuring and control technology Pneumatically actuated process valves Manual ball valves Multiple clamp connection ports Connection and distribution panels Height-adjustable stainless steel leveling feet Compact, ready-to-operate skid Function & Application: The BRINOX LEP 11 Chromatography and CIP Skid Unit PP6713 is designed for: Hygienic transfer, separation, and forwarding of process media Integration into chromatography or cleaning processes Temperature and flow control within a pharmaceutical process loop Connection to CIP/SIP systems and supply utilities Typical Fields of Application: Pharmaceutical and biotechnology production Cleaning systems with CIP integration Chromatography process lines Hygienic production and laboratory environments Condition Description: As-new, original packaging, unused Project-specific unit without operating hours Clean stainless steel surfaces Professionally assembled components Ready for transport and installation Documentation: The unit is fully documented, including: Material lists Material certificates / EN 10204 FDA-/USP-compliant seals Kedeyl Rnnepfx Afaoln Welding documentation Instrumentation and piping records Connection and isometric diagrams (Full documentation available upon request.) Special Features: Pharmaceutical-grade hygienic design Stainless steel in 1.4435 / 1.4404 quality Pneumatically controlled valve technology Skid system for easy integration Immediately available – unused

Condition: new, Year of construction: 2020, functionality: fully functional, Equipment: documentation/manual, Manufacturer: BRINOX process systems Type: LEP 11 Project No.: B-0001113-LEP11 Project scope: Chromatography Machine No.: 1003604 Year of manufacture: 2020 Condition: New, original packaging Status: FAT performed and documented Description For sale is an unused, originally packaged Brinox LEP 11 system designed for pharmaceutical chromatography applications. This is a high-quality stainless steel process system for media distribution, pressure and flow control, as well as integration into chromatographic processes. Complete technical documentation, including FAT (Factory Acceptance Test) records, is available. The system has undergone a comprehensive Factory Acceptance Test (FAT). The inspections included, among others: – FAT plan and report – Layout and drawing inspection – P&ID verification – Leak testing – Surface inspection Klodpfjyl Ndnjx Afaon – Sensor calibration – Documentation review – Welding documentation inspection Welding documentation was checked according to AD2000 standards. WPQR, WPS, welding certificates, isometrics, material certificates and traceability are fully documented (see inspection reports IT-11.0 and IT-11.1). Technical Specification – Stainless steel process design for pharmaceutical applications – Hygienic design – Full documentation in accordance with GMP requirements – Integrated measurement and sensor technology – Pressure and flow measurement – Temperature monitoring – Limit value monitoring – Valve technology and control valves – Complete welding documentation package – Material certificates (LBM material list) – Polymer and EU Declarations of Conformity Scope of Documentation – FAT documentation – Technical documentation – User documentation – CIP master documentation – Vessel master documentation – Welding documentation incl. WPQR / WPS – Leak test protocols – Sensor calibration certificates – Inspection protocols documentation – Isometric drawings – Material certificates and traceability Condition The system is new, unused, and in its original packaging. No use in production operations. Complete project documentation available.

Year of construction: 2020, condition: new, functionality: fully functional, Manufacturer: BRINOX Type: LEP 11 – CIP Skid Year of manufacture: 2020 Version: Pharma / GMP Condition: New, unused, original packaging Package 1 CS6710 - CIP Machine type: Pharmaceutical CIP System (Cleaning in Place) as compact package unit on stainless steel frame. Application: For automated cleaning of process plants, chromatography systems, tanks, and piping systems in the pharmaceutical, biotech, and chemical industries. Suitable for NaOH, acetic acid, WFI, PW, and other cleaning media. Technical data: Heating capacity of CIP medium: from +5°C to +80°C in max. 10 minutes Pumping capacity: 1 – 4 m³/h (adjustable) Operating pressure at CIP supply: 1 – 3 bar (adjustable) Measurement ranges: Flow: 0 – 10 m³/h Temperature: 0 – +150°C Pressure: 0 – 6 bar Design pressure: -0.9 to +6 bar Design temperature: +2 to +95°C Klodeyl Hwlspfx Afaon Design features: • Compact package unit on stainless steel frame • CIP supply pump as centrifugal pump • Shell and tube heat exchanger with leakage-proof design • Height-adjustable dome feet • Completely drainable construction • Maintenance-friendly layout • Industrial heavy-duty design Materials & GMP execution: • Product- and cleaning-contact components made of stainless steel 1.4435 • Electropolished surfaces Ra ≤ 0.8 µm • FDA-compliant seals (EPDM / PTFE / silicone) • Designed for NaOH 0.3 mol/L at +80°C • Resistant to acetic acid, WFIH, WFIC, PUW Documentation & Quality: • Complete GMP documentation • CE conformity • 3.1 material certificates • Full welding protocols • Weld seam documentation including photo documentation • Pressure and tightness tests documented • FAT documentation available • Drainability and final rinse certificates available Condition: • New • Unused • Original packaging • No production hours • Immediately available Special features: • Very high thermal cleaning performance • Fully adjustable process operation • Top pharmaceutical GMP execution • High-quality European components • Investment-secure system with complete documentation Location: Germany Inspection possible by appointment